NCT01383863

Brief Summary

The purpose of the protocol is to assess the rate of castration resistance, disease progression and overall survival over a 3-year period post-androgen deprivation therapy (ADT) induction in a study cohort of patients with advanced disease.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2011

Typical duration for all trials

Geographic Reach
7 countries

35 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

January 14, 2019

Status Verified

January 1, 2019

Enrollment Period

2.6 years

First QC Date

June 27, 2011

Last Update Submit

January 11, 2019

Conditions

Advanced Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Castration-resistant prostate cancer (CRPC)

    Over a 3-year period post-androgen deprivation therapy induction

Secondary Outcomes (4)

  • Disease progression (DP) rate post-androgen deprivation therapy induction

    Over a 3-year period post-androgen deprivation therapy induction

  • Overall survival

    3-years post-androgen deprivation therapy induction

  • Serum prostate specific antigen

    Over a 3-year period post-androgen deprivation therapy induction

  • Serum testosterone

    Over a 3-year period post-androgen deprivation therapy induction

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with previously diagnosed advanced prostate cancer, and who have participated in the Triptocare study and who have given written informed consent to participate in the study. They have therefore been treated with triptorelin (22.5 mg, intamuscular) as an ADT induction.

You may qualify if:

  • Have participated and received study treatment in the Triptocare study
  • Be aware of the investigational nature of this observational study cohort and must give written (personally signed and dated) informed consent

You may not qualify if:

  • Absence of written informed consent from the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

Fredericia Sygehus

Fredericia, Denmark

Location

Frederiksbergs Hospital

Frederiksberg, Denmark

Location

Herlev University Hospital

Herlev, Denmark

Location

Odense Universitets Hospital

Odense, Denmark

Location

Clinique Rhône Durance

Avignon, 84000, France

Location

Hôpital Pellegrin

Bordeaux, 33076, France

Location

CHU Henri Mondor

Créteil, 94010, France

Location

Chru Lille

Lille, 59037, France

Location

Hôpital Nord

Marseille, 13915, France

Location

Clinique Beau Soleil

Montpellier, 34000, France

Location

Private practice

Nancy, 5410, France

Location

CHU Nantes

Nantes, 44093, France

Location

CHU Pasteur

Nice, 0600, France

Location

Hôpital Val de Grâce

Paris, 75005, France

Location

Institut Mutualiste Monsouris

Paris, 75014, France

Location

Hôpital Henry Gabrielle

Saint-Genis-Laval, 69230, France

Location

Hôpital Foch

Suresnes, 92150, France

Location

P.Stradins Clinical University Hospital

Riga, LV 1002, Latvia

Location

Center of Oncology

Riga, LV1079, Latvia

Location

Medical University Clinics

Kaunas, Lithuania

Location

University Hospital

Klaipėda, Lithuania

Location

University Oncological Institute

Vilnius, Lithuania

Location

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Diaconessenhuis

Leiden, Netherlands

Location

Medical Center

Arad, Romania

Location

Sc E-Uro Srl

Cluj-Napoca, Romania

Location

Oncomed

Timișoara, Romania

Location

Ulster hospital

Belfast, United Kingdom

Location

Bristol Royal Infirmary

Bristol, United Kingdom

Location

Addenbrookes Hospital

Cambridge, CB2 8RP, United Kingdom

Location

University Hospital Wales

Cardiff, CF14 4XW, United Kingdom

Location

University Hospital Coventry

Coventry, CV3 / CV2 2DX, United Kingdom

Location

Leicester General Hospital

Leicester, LE5 4PW, United Kingdom

Location

Nottingham City Hospital

Nottingham, NG5 1PB, United Kingdom

Location

Lister Hospital

Stevenage, SG1 4AB, United Kingdom

Location

Related Links

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2011

First Posted

June 28, 2011

Study Start

October 1, 2011

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

January 14, 2019

Record last verified: 2019-01

Locations

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